Pds Biotechnology Corporation Stock Price, News & Analysis

PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy firm, announced participation in the B. Riley Securities 3rd Annual Oncology Conference, set for January 18-19, 2023. A fireside chat with management will occur on January 19, 2023, at 1:00 PM EST, accessible via livestream. PDS Biotech focuses on developing targeted immunotherapies for cancer and infectious diseases using its proprietary Versamune^® and Infectimune™ platforms, showing promise in clinical trials for HPV-expressing cancers.

PDS Biotech has announced an exclusive global license agreement with Merck KGaA for the IL-12 fusion protein M9241, now referred to as PDS0301. The agreement includes a $5 million upfront payment and potential milestone payments totaling up to $116 million, along with a 10% royalty on future sales. M9241 is designed to enhance T cell effectiveness in tumor environments.

Clinical data shows promising results in treating advanced HPV-positive cancers, with significant improvements in survival rates and tumor response compared to standard therapies. A meeting with the FDA is scheduled to discuss a registrational trial.

PDS Biotechnology Corporation (Nasdaq: PDSB) announced promising interim results from its Phase 2 trial of PDS0101, a triple therapy for HPV16-positive cancers. The data revealed a median overall survival (OS) of 21 months in 29 checkpoint inhibitor (CPI) refractory patients, compared to a historical median of 3-4 months. Among CPI-naive patients, 75% remained alive at a median follow-up of 27 months. The objective response rate was 63% in CPI refractory and 88% in CPI naive patients. The trial demonstrates the therapy's durability and tolerability, with 48% reporting Grade 3 adverse events.

PDS Biotechnology Corporation announced the completion of enrollment in the first stage of its VERSATILE-002 Phase 2 study, investigating PDS0101 in combination with Merck’s KEYTRUDA for recurrent and/or metastatic HPV16-positive head and neck cancer. Positive preliminary data from 17 patients showed a 41% objective response rate and 87% overall survival at nine months. The study targets both checkpoint inhibitor refractory and naïve patients, with potential advancements based on initial efficacy results. This highlights a critical milestone in the company's pursuit to improve treatment options for advanced head and neck cancers.

PDS Biotechnology Corporation (PDSB) announced preliminary results from its PDS0101 Phase 2 clinical studies at SITC 2022, highlighting 100% clinical response in locally advanced cervical cancer patients. The company reported a successful end-of-Phase 2 meeting with the FDA for VERSATILE-002, advancing to a registrational trial. Financially, PDSB experienced a net loss of $7.4 million for Q3 2022, slightly up from $7.0 million in Q3 2021, driven by increased R&D costs. The cash balance as of September 30, 2022, stood at $71.6 million, supporting ongoing clinical programs.

PDS Biotechnology Corporation (PDSB) recently presented updated data from its ongoing IMMUNOCERV Phase 2 clinical trial at the Society for Immunotherapy of Cancer (SITC 2022). The study, which explores PDS0101 combined with standard chemoradiotherapy (CRT) for advanced cervical cancer, reported that 100% of patients exhibited tumor shrinkage of over 60% at midpoint evaluations. Additionally, 89% showed no evidence of disease by day 170. The data indicates that PDS0101 effectively activates HPV16-specific T cells, suggesting a promising new treatment approach for cervical cancer.

PDS Biotechnology Corporation (Nasdaq: PDSB) announced significant findings from two Phase 2 clinical trials of PDS0101, an immunotherapy for HPV-positive cancers, to be presented at the SITC 2022. The IMMUNOCERV trial showed a 100% 1-year overall survival rate among patients receiving PDS0101 with chemotherapy and radiation, with 87.5% achieving complete response. Additionally, a triple combination trial indicated a more than two-fold increase in HPV-specific T cells in 79% of patients. The results suggest PDS0101's potential to enhance therapeutic responses in challenging cancer cases.

PDS Biotechnology Corporation (Nasdaq: PDSB) will announce its third-quarter financial results on November 14, 2022, prior to market opening. A conference call will follow to discuss the results and provide a business update. The company focuses on developing immunotherapies targeting cancer and infectious diseases, utilizing its proprietary Versamune® and Infectimune™ technologies. The lead candidate, PDS0101, has shown promise in clinical trials for HPV-positive cancers.

PDS Biotechnology Corporation (Nasdaq: PDSB) recently hosted a Head and Neck Cancer KOL Roundtable to discuss advancements in treatment for HPV-positive cancers, focusing on PDS0101 and its combination with KEYTRUDA®. Lead Investigator Jared Weiss presented interim data from the VERSATILE-002 clinical trial, reporting an objective response rate of 41.5%, with a clinical benefit rate of 76.5% and an overall survival rate of 87.2% at nine months. The event highlighted unmet medical needs in head and neck cancer and PDS0101's potential role in treatment protocols.